Topical Formulations of Liposomal Local Anesthetics

Phase 1

Completed

• Conditions: Administration, Topical Drug; Administration, Topical; Anesthetic Drugs
• Interventions: Drug: Ropivacaine

• Registration Number: NCT01054547
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.

Detailed Description

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.

Study Timeline

• Status Verified: 2006-05
• Study Start: 2006-09
• Primary Completion: 2006-12
• Study Completion: 2007-04
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-21
• Last Update Submitted: 2010-01-21
• Study First Posted: 2010-01-22
• Last Update Posted: 2010-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Healthy

Exclusion Criteria

• Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Liposomal ropivacaine, palatal mucosa	Ropivacaine	Topical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution.
Liposomal ropivacaine, topical	Ropivacaine	The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa.

Primary Outcome Measures

Name	Time	Method
After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester.	10 minutes

Secondary Outcome Measures

Name	Time	Method
The efficacy of the topical anesthetics was measured after a simulation of a local anesthesia in the application site (insertion of a 30 gauge needle until periosteum contact).	10 seconds after removal of topical formulation

Trial Locations

Locations (1)

Piracicaba Dental School; 🇧🇷 Piracicaba, Sao Paulo, Brazil